Endotracheal intubation is a medical procedure used to place an airway device (artificial airway) into a patient's trachea or airway. The use of an airway device is mandated in situations where an individual is unable to sustain the natural breathing function or maintain an open airway on his or her own due to unconsciousness, trauma, disease, drugs or anesthesia. Thus, life-saving mechanical ventilation is provided through the airway device which may be in the form of an endotracheal tube (ETT), or a supraglottic airway device such as a laryngeal mask airway (LMA), King Airway, or one of several other commercially available airway devices.
Endotracheal intubation is accomplished by inserting an airway device into the mouth, down through the throat and vocal cords or voice box, and into the trachea. This procedure creates an artificial passageway through which air can freely and continuously flow in and out of lungs and prevents the patient's airway from collapsing or occluding.
It is very important that the airway device be positioned correctly and maintained in the correct position in the trachea. If the device moves out of its proper position in the trachea and into either the right or left main stem bronchial tube, only one lung will be ventilated. Failure to ventilate the other lung can lead to a host of severe pulmonary complications. Moreover, if the airway device moves completely out of the trachea and into the esophagus, the patient will become hypoxic due to the lack of ventilation to the lungs, a condition which typically results in life-threatening brain injury within a matter of only a few minutes.
Even after an airway device has been positioned correctly, subsequent movement of the patient can lead to inadvertent movement of the device, as hereinabove described. An intubated patient may restlessly move about and may also attempt to forcibly remove an airway device, whether conscious or unconscious, particularly if the patient is uncomfortable or having difficulty breathing, which can lead to panic. Because medical emergencies may occur anywhere, emergency medical service personal (i.e., paramedics) may be called upon to insert airway devices in out-of-hospital emergency settings as well as in hospital settings by emergency department, operating room, and critical care personnel. Therefore, such unintentional movement is not uncommon, particularly when the patient is moved from an out-of-hospital setting, such as an accident scene, to an emergency department of a hospital. Further, anytime an intubated patient may be moved, for example, not only from an ambulance to a trauma facility, but also from one hospital to another hospital, from one area of the hospital to another area in the same hospital (imaging, laboratory, operating theater), or from a hospital to an outpatient rehabilitation facility, unintentional movement of an airway device is a risk. Even repositioning an intubated patient in a hospital bed may cause unintentional movement of the endotracheal tube.
Inadvertent movement of an airway device may also occur as a result of moving external ventilation equipment, such as a conventional mechanical ventilator or bag valve mask, connected thereto where the patient can no longer naturally achieve respiration. Typically, the external ventilation equipment is connected to the external end of the device by an air conduit to establish air flow to and from the lungs. Inadvertent pulling on, or other excessive movement of the air conduit, may transfer movement to the airway device, thereby shifting it from its proper position and causing unplanned extubation.
Unplanned extubation is a hazardous and costly problem which studies have demonstrated occurs at an unacceptably high rate. A study completed by Carson et al reports that approximately 950,000 patients are mechanically ventilated in the United States annually. Carson et al., The Changing Epidemiology of Mechanical Ventilation: A Population-Based Study. Journal of Intensive Care Medicine. 2006 February; 21(3): pp. 173-182. A review of the world-wide medical literature suggests that the world-wide rate of unplanned extubation averages approximately 7.31%. Lucas de Silva, Unplanned Endotracheal Extubations in the Intensive Care Unit: Systematic Review, Critical Appraisal, and Evidence-Based Recommendations. Anesth Analg 2012; 114:1003-14. Applying the world-wide average to the U.S. figure above, an estimated 68,000 patients in the United States alone experience an unplanned extubation each year. Such unplanned extubations are costly, not only for patients who experience increased rates of morbidity and mortality, but also for hospitals, physicians and insurance companies who incur the liability costs associated therewith. The annual intensive care unit (ICU) bed cost associated with unplanned extubations in the United States alone is estimated at $2.6 M, which includes imaging, pharmacy, and laboratory expenses. (Extrapolated using data from the Carson study referenced above and the cost of long-term care according to the U.S. Department of Health and Human Services National Clearinghouse for long-term care information. See also S. K. Epstein, M. L. Nevins & J. Chung, Effect of Unplanned Extubation on Outcome of Mechanical Ventilation, Am. Journal of Respiratory and Critical Care Medicine, 161: 1912-1916 (2000) which discusses the increased likelihood of long-term care outcome). Moreover, it is not unknown for jury damage awards in personal injury law suits arising from unplanned extubations to be in excess of $35 M. The high incidence of unplanned extubation and the associated increase in healthcare costs implies that an improved restraining system, which has the capacity to resist the application of greater forces which would otherwise result in movement of the airway device is sorely needed.
Various prior art systems have attempted to address the problem of maintaining an airway device in the correct position and preventing unintentional extubation. The most common approach for securing an airway device (typically, an endotracheal tube) is with adhesive tape. Umbilical tape may be used as an alternative. Both present the same challenges. The tape is tied around the patient's neck and then wrapped and tied around the smooth outside surface of the endotracheal tube itself. Arranged in this fashion, the tape is intended to anchor the endotracheal tube to the corner of the patient's mouth and prevent its unintentional movement. While the use of tape in this manner provides some benefit, the restraint available from the tape usually diminishes because the tape becomes covered and/or saturated with blood, saliva, or other bodily fluids. Consequently, the endotracheal tube may be readily moved from its preferred position in the patient's trachea, and this form of securing an airway device provides inadequate protection against movement resulting from the application of multidirectional forces such as bending, torsional/rotational or substantial lateral forces to the device. Such forces may exceed fifty (50) pounds in magnitude, and, as shown in the results of two studies of the restraint capabilities of current devices and methods set forth in Tables 1 and 2 below, such devices and methods do not provide sufficient resistance to prevent unplanned extubation. Clinically significant movement is defined as longitudinal movement of the airway device in a direction towards or away from the patient's mouth to a point where the tip of the airway device has moved beyond the vocal cords. Typically, such movement is in the range of five (5) to seven (7) centimeters.